Kornimate/medical-research-clean huggingface dataset:
study to determine if a reduction in pain can be measured in spinal cord injured patients using a new study design

Conditions: Spinal Cord Injuries

Summary: the study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. patients had either pain at the level of their injury or below the level of their injury.

this methodology study was terminated on october 13, 2008 based on interim results for an exploratory, novel endpoint. the results of the primary analysis at the interim for n=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. based on the estimated conditional power, this result is unlikely to change with full recruitment of n=24 patients and therefore the data monitoring committee recommended termination of the trial. the decision to terminate the trial was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: * subjects who are outpatients or inpatients * written informed consent obtained (signed by the subject or the subject's legally acceptable representative) * traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration * at-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury * below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury exclusion criteria: * spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two) * subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline

Keywords: clinical trial methodology study neuropathic pain in spinal cord injury patients pain endpoints crossover design
r-ice and high-dose cyclophosphamide with pet/ct for diffuse large b-cell non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this research is being done to see if a pet scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called non-hodgkin's lymphoma. the standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the chop combination (cyclophosphamide, doxorubicin, vincristine, and prednisone). this regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). relapses are generally treated with more chemotherapy. we believe that a pet scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse. the purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive pet scan will have longer remissions than they would if they did not receive that high dose chemotherapy.

patients will receive 3 cycles of chemotherapy prior to mid-treatment pet-ct. rituximab-chop, or an equivalent regimen must be used. during the third cycle of rituximab-chop chemotherapy, a pet-ct scan will be performed. the pet scan will be designated as negative or positive. based on the results, patients will either complete standard dose therapy or receive two cycles of r-ice followed by high dose cyclophosphamide and rituximab. a repeat pet-ct is required between 4 to 6 weeks following treatment completion. patients will be followed-up every 4 months for 2 years, then every 6 months for one year, then annually until 5 years.

Eligibility criteria:
inclusion criteria: * one of the following biopsy-confirmed, aggressive non-hodgkin's lymphoma 1. diffuse large b-cell lymphoma 2. mediastinal (thymic) b-cell lymphoma * any stage (i through iv) as defined by the ann arbor staging system * ecog performance status of 0 to 2 * radiographically measurable disease * no more than 3 cycles of chemotherapy for lymphoma * greater than or equal to 18 years * adequate pulmonary, cardiac, hepatic, or renal function * hiv antibody negative * women- not pregnant or breastfeeding * men of reproductive potential must agree to use contraception exclusion criteria: * patients with the following aggressive lymphomas are not eligible: 1. mantle cell 2. lymphoblastic 3. burkitt's 4. mycosis fungoides/sezary's syndrome 5. htlv-1 associated t-cell leukemia/lymphoma 6. primary cns lymphoma 7. hiv-associated lymphoma 8. transformed lymphomas 9. immunodeficiency-associated lymphomas * previous diagnosis of another hematologic malignancies * progressive disease on chop or rituximab-chop * active cns involvement by lymphoma * serious co-morbid disease that could preclude full participation in study

Keywords: b-cell non-hodgkin's lymphoma
scentaware and oct in mci vs hc

Conditions: Alzheimer Disease, Early Onset

Summary: the goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of alzheimer's disease. the main questions it aims to answer are: * whether the test is as effective and reliable as the standard test * whether there is a link between the results of the smell test and the structure of the back of the eye participants will: * complete a short questionnaire * have pictures of the inside of their eyes taken * perform two smell tests


Eligibility criteria:
inclusion criteria: * adults who are ≥ 50 and ≤ 80 years of age * fluent in english * able to provide written consent * able to complete a 2.5-3-hour clinical visit, including sitting for spectral domain optical coherence tomography (sd-oct) imaging for 30 minutes and taking cognitive and olfactory tests for 90-120 minutes * cognitive ability and family history of alzheimer's disease/mild cognitive impairment (ad/mci): * cohort 1: cognitively unimpaired, no family history of mci or ad, and mmse ≥ 26 * cohort 2: cognitively unimpaired, a positive family history of mci or ad, and mmse ≥ 26 * cohort 3: an mmse score \> 22 and ≤ 25 and either * clinically diagnosed mci due to ad * a participant in a wisconsin adrc research registry with either clinically diagnosed mci or self-reported mci * cohorts 1 and 2: proficient in independent use of mobile smart devices exclusion criteria: * a history of significant ocular or nasal trauma that required medical/surgical intervention * a history of intraocular surgery except cataract extraction * a cataract extraction within 3 months prior to enrollment * diagnosis of visually significant intraocular disease (such as late-stage age-related macular degeneration, glaucoma, or other optic nerve conditions related to brain tumor or multiple sclerosis), drug related vision loss or retinal damage * optic neuritis on both eyes * current use of medications that may interfere with olfactory functions * current use of hydroxychloroquine and tamoxifen, which are known to cause retinal toxicity that may confound oct interpretation * a history of recurrent or chronic oto-pharyngeal-laryngeal (orl) disease (such as chronic rhinitis, nasal polyposis, or sinus disease), head trauma, toxic exposures, upper respiratory infections at time of assessment * a family history or diagnosis of other neurodegenerative diseases (e.g., multiple sclerosis, parkinson's disease, huntington's disease) or conditions that, in the opinion of the investigators, may affect cognitive or olfactory functions * olfactory loss due to covid (current olfactory loss and/or temporary loss that has been regained)
safety, pk and pd study in healthy male japanese subjects

Conditions: Schizophrenia

Summary: study assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of oral doses of sca-136 in healthy male japanese subjects


Eligibility criteria:
inclusion criteria * men aged 20 to 45 years at the time of obtaining informed consent. * body mass index (bmi) in the range of 18.5 to 25.0 kg/m2 and body weight ≥ 50 kg. * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ecg). exclusion criteria * presence or history of any disorder that may prevent the successful completion of the study. * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion (adme) of the test article (eg, resection of liver, kidney, or gastrointestinal tract).
real-life data of olaparib in relapsed ovarian cancers patients

Conditions: Relapsed Ovarian Cancers Patients

Summary: this is a national, multi center, retrospective observational cohort study that will be carried out by reviewing the medical records of patients with relapsed epithelial ovarian, fallopian tube, or peritoneal cancer treated with olaparib following response to platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * patients must be female ≥18 years of age * patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer that were treated with olaparib in a real life-setting, between may 2014 to march 2017, whatever the line of therapy * patients can be either alive or deceased at the time of medical record abstraction * patients should not have any objection that anonymized data will be collected and subjected to automated processing. exclusion criteria: * patient that were given olaparib within a clinical trial
efficacy of positional release muscles for neck pain during lactation

Conditions: Post Partum Neck Pain

Summary: purpose of the study: to determine the efficacy of neck muscles positional release for neck pain during lactation.methods:fifty patient with postpartum neck pain will be recruited. patients will be randomly assigned into two groups, group a and group b . patients in both groups will receive posture correction advices during lactation and posture correction exercises but group a will receive additional positional release for upper trapezius. all patients will be evaluated for pressure pain threshold (ppt) of upper trapezius by algometry, neck disability using arabic version of neck disability index, pain intensity using 11-numerical rating scale.

treatment procedure both groups will receive posture education advices during lactation and posture correction exercise program which will include strengthening exercise program and spinal stretches. strengthening exercise program included neck isometrics, abdominal strengthening and pelvic floor exercises 10-12 repetitions twice a day .spinal stretches were also included .in the intervention program mothers who underwent normal delivery were advised to start home based exercise program after 5 weeks and the caesarean mothers after 2 months of delivery group (a): will receive positional release of neck muscles in addition to posture correction.positional release technique for deactivation of trigger points (trps) and decrease spasm manual approaches. \[prt\] was developed by lawrence h. prt is a method in which muscles are placed in a position of greatest comfort, and this causes normalization of muscle hypertonicity and fascial tension. also, it decreases joint hypomobility, increases circulation, followed by a reduction in swelling, decreased pain, and increase muscle strength. the practical section of the study will be undertaken in 4 weeks (3 sessions a week). measurement will be taken before the start of treatment program then after the end of 4 weeks treatment program.

Eligibility criteria:
inclusion criteria: * lactating mothers. * age between 25-35 years old. * six weeks to one year after childbirth. * at least a moderate level of education. exclusion criteria: * mothers were excluded if they had facet joint, neurological, or cardio vascular and respiratory conditions. * history of breast cancer.
rd13-02 for patients with r/r cd7+ t cell hematologic malignancies

Conditions: Hematologic Malignancies

Summary: this is a single-arm, open-label, single-center, phase i study. the primary objective is to evaluate the safety of cd7 car-t therapy for patients with cd7-positive relapsed or refractory t-all/lbl, and to evaluate the pharmacokinetics of cd7 car-t in patients.


Eligibility criteria:
inclusion criteria: 1. age 3-70 2. diagnosis of r/r t-all/lbl. 3. cd7 positive expression 4. bone marrow lymphoblasts ≥5% by morphologic evaluation at screening 5. creatinine clearance (as estimated by cockcroft gault) ≥ 60 ml/min, serum alanine aminotransferase(alt)/aspartate aminotransferase(ast) \< 3×upper limit of normal, total bilirubin \< 1.5×upper limit of normal or ≤1.5mg/dl 6. left ventricular ejection fraction ≥ 50% . 7. baseline oxygen saturation ≥ 92% on room air. 8. ecog performance status of 0 to 2. 9. the estimated survival time is more than 3 months. 10. subjects or their legal guardians volunteer to participate in the study and sign the informed consent. exclusion criteria: 1. subjects with concomitant genetic syndromes associated with bone marrow failure states. 2. isolated extramedullary lesions 3. subjects with some cardiac conditions will be excluded. 4. with uncontrolled active central nervous system leukemia (cnsl), cerebrospinal fluid grade cns3. 5. history of traumatic brain injury, consciousness disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic disease, which might compromise the ability of the subject to compliance with the obligations under the protocol. 6. history of malignancy other than non-melanoma skin cancer or carcinoma. 7. primary immune deficiency. 8. presence of uncontrolled infections. 9. sujects with some anticancer therapy before car-t infusion will be excluded. 10. active uncontrolled acute infections. 11. known history of infection with human immunodeficiency virus (hiv); active or latent hepatitis b, hepatitis c and syphilis. 12. subjects who are receiving systemic steroid therapy prior to screening. 13. subjects with acute graft-versus-host disease (gvhd) 14. having received live/attenuated vaccine within 4 weeks prior to screening. 15. history of allergy to any component of the cell therapy product. 16. pregnant or breastfeeding women 17. any other issue which, in the opinion of the investigator, would make the sujects ineligible for the study.
estrogen for triple negative breast cancer

Conditions: Female Breast Cancer

Summary: the purpose of this study is to determine the effectiveness of estradiol treatment for advanced breast cancer that is hormone receptor negative and her2/neu negative. the study will also use tumor tissue from your original diagnosis or from a biopsy you may have had for your cancer to look at hormone receptors in the lab. the tissue left over from your previous surgery or a previous biopsy will be used for research tests to check whether a different estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen work better.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer which is metastatic. * a formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from either a prior biopsy of the primary tumor or a metastatic site. . * primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and her2 negative * patients must have measurable disease. * eastern cooperative oncology group performance status 0-1. * patients with bone metastasis at baseline must agree to treatment with intravenous bisphosphonates * subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy regimens administered for treatment of their metastatic breast cancer. * age \>18 years * life expectancy of greater than 3 months. * patients must have adequate organ and marrow function as defined below: exclusion criteria: * systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2 weeks prior to entering the study * patients receiving any other investigational agents for breast cancer treatment. * patients with known brain metastases are excluded 3.2.4 history of allergic reactions attributed to compounds of similar chemical or biologic composition to estradiol. * patients with any condition of the gastrointestinal tract that is expected to result in an inability to take oral medication * dysfunctional or post-menopausal vaginal bleeding. * uncontrolled hypercalcemia/hypocalcemia * prior history of or active thrombophlebitis, cerebral vascular accident, myocardial infarction, deep venous thrombosis or pulmonary embolism. * history of or active hepatic adenoma. * uncontrolled intercurrent illness * pregnant women are excluded from this study * patients with bone metastasis are excluded if they are unable to receive intravenous bisphosphonate therapy due to the risk for developing hypercalcemia.

Keywords: breast cancer
healthy infant development project - sucrose component

Conditions: Iron Deficiency

Summary: iron deficiency affects the opioid and dopamine systems in rodent models, with a higher pain threshold. the opioid system is involved in sucrose's ability to reduce pain and distress during neonatal procedures. thus, prenatal iron deficiency might affect response to pain and sucrose analgesia. in order to compare response to pain and sucrose during heel stick in neonates with and without iron deficiency, healthy full-term chinese infants were randomized to receive sucrose or water by syringe beforehand, in conjunction with heel stick for metabolic screening.


Eligibility criteria:
inclusion criteria: * full term healthy neonates participating in the healthy infant development rct (nct00613717) in the folic acid/early postnatal placebo group and pre- and early postnatal iron-supplemented infants. exclusion criteria: * birth weight \< 2500 g gestational age ≤ 37 wk major perinatal complications major congenital anomaly multiple birth
comparisons of treatment responses of early syphilis to benzathine penicillin g with or without doxycycline

Conditions: Early Syphilis, Latent, Serological Relapse After Treatment

Summary: this randomized controlled superiority study will be conducted during 2023-2025. the eligible participants are adult people living with hiv (plwh) who are newly diagnosed with early syphilis. participants will be randomized in a 1:1 ratio to receive single-dose benzathine penicillin g (bpg) (2.4 mu intramuscularly once) plus doxycycline (100 mg orally twice daily for 7 days) or single-dose bpg. the primary outcome is serologic response, defined as a decline of rapid plasma reagin (rpr) titer by 4-fold or greater, at week 24 and week 48; and the secondary outcomes include microbiologic response of syphilis and bacterial sexually transmitted infections (stis) assessed by nucleic-acid amplification test (naat) at week 4.


Eligibility criteria:
inclusion criteria: * people living with hiv (plwh) aged ≥18 years with early syphilis * confirmed by a positive rpr titer with a reactive tppa assay exclusion criteria: * pwh with rpr titers of \<4 * exposure to antibiotics with activity against t. pallidum within the preceding 4 weeks (penicillin, 3rd cephalosporin, doxycycline, macrolides) * a known or suspected infection requiring additional treatment with an antimicrobial active against t. pallidum (penicillin, 3rd cephalosporin, doxycycline, macrolides) * testing positive for c. trachomatis and m. genitalium, for which doxycycline or macrolide was administered * a history of intolerance to penicillin or doxycycline * plwh have already participated in this study * pregnancy

Keywords: syphilis rapid plasma reagin
acute coronary disease (acs)- strain

Conditions: Cardiac and Non Cardiac Thoracal Disorder

Summary: examination of probable distinction between cardiac or non- cardiac thoracal disorder via echocardiographic myocardial strain analysis

patients with cardiac disorder have to undergo time- consuming and expensive examinations such as laboratory of cardiac biomarkers or ischemic diagnostic. to save time and money in this observational registry the probable distinction between cardiac and non- cardiac disorder in patients with vague thoracal disorder and the probability for coronary artery disease (determined via grace score) is examined via echographic myocardial strain analysis in 300 patients retrospectively to establish a cut off value corresponding to acute coronary disease also to prevent coronary angiography. therefore patients undergo echography routinely with consecutive evaluation of systolic, diastolic and strain analysis to elevate exact statements with reference to deformation of the myocard and its velocity. several study have shown that these strain parameters (circumferential and radial strain) enable vitality and ischemic diagnosis and therefore could be eligible for this purpose.

Eligibility criteria:
inclusion criteria: * thoracal cardiac or non cardiac disorder * signed informed consent exclusion criteria: * glomerular filtration rate (gfr) \< 60 ml/min * angina pectoris * acute myocardial infarction within 3 months prior inclusion * pregnancy

Keywords: acute coronary disease, echographic strain analysis, cut off
rates of apnea in patients undergoing vitreoretinal surgery

Conditions: Apnea

Summary: the purpose of this study is to determine if apnea (the stopping of breathing) occurs in patients undergoing undergoing monitored anesthesia care (mac) for vitreoretinal surgery

patients undergoing vitreoretinal surgery will be monitored during the procedure to determine if they stop breathing. this study is observational in nature and no interventions will be made.

Eligibility criteria:
inclusion criteria: * patients having vitreoretinal surgery under monitored anesthesia care exclusion criteria: * patients having vitreoretinal surgery without monitored anesthesia care
reshaping postpartum follow-up

Conditions: Hypertension in Pregnancy; Gestational Diabetes; Cervical Dysplasia

Summary: the aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. the intervention will consist of a card given to patients at time of discharge. one side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge. the primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. the secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated.


Eligibility criteria:
inclusion criteria: * subjects \>=18 years of age * ability to read english or spanish * delivered via vaginal delivery or c-section within the past 48 hours * able to consent for themselves exclusion criteria: * received antepartum care at a facility outside of the medstar system or plans to continue care with a facility outside of the medstar system

Keywords: postpartum followup hypertensive disorders of pregnancy eclampsia pre-eclampsia pap smear gestational diabetes